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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Esaote Endocavity Ultrasonic Probes Recalled Due to Liquid Leak Risk

Agency Publication Date: March 3, 2026
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Summary

ESAOTE S.P.A. is recalling 5 units of the Esaote Endocavity ultrasonic probe, Model E 3-12, because a manufacturing defect in a specific batch may cause liquid to leak from the casing near the cable. This weakness in the probe body can allow fluids to enter the device during use or cleaning. Consumers and healthcare facilities in North Carolina and Texas should immediately identify if they have the affected serial numbers and contact the manufacturer to arrange for a return or replacement.

Risk

The compromised casing allows liquid to leak into the terminal part of the probe body, which could lead to device failure, electrical shorting, or cross-contamination between patients if the probe cannot be properly disinfected.

What You Should Do

  1. Identify if you have the Esaote Endocavity ultrasonic probe, Model E 3-12 (REF 120000038) by checking the label for UDI 0805604453891.
  2. Check the serial number on your device; only units with serial numbers 241700533C, 241700529C, 241700607C, 241700536C, and 241700613C are included in this recall.
  3. Stop using the recalled product immediately to prevent potential liquid ingress.
  4. Contact the manufacturer or your distributor to arrange for a return, replacement, or correction of the device.
  5. Call the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls if you have additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Esaote Endocavity ultrasonic probe, Model E 3-12
Model / REF:
E 3-12
REF 120000038
Serial Numbers:
241700533C
241700529C
241700607C
241700536C
241700613C
UDI:
0805604453891

Recall number Z-1490-2026.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98339
Status: Resolved
Manufacturer: ESAOTE S.P.A.
Sold By: Direct distribution
Manufactured In: Italy
Units Affected: 5 units
Distributed To: North Carolina, Texas

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.